Identity® 5180Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05414734006804), received between Jun 22, 2018 and Apr 15, 2022 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Interrogate” (3 reports).

9 other recalls cover devices cleared under the same FDA submission (P880086); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE DEVICE WAS EXPLANTED AND REPLACED AFTER REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) LEVEL. IT IS UNKNOWN WHETHER OR NOT THE PHYSIOLOGIST ALLEGED A MALFUNCTION AGAINST THE DEVICE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14119472 ↗
• InjuryApr 8, 2022Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. THE DEVICE WAS UNABLE TO BE INTERROGATED AND THE PHYSICIAN ALLEGED PREMATURE BATTERY DEPLETION OF THE PACEMAKER. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE PACEMAKER. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER THE PROCEDURE.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions; Syncope/Fainting

  MAUDE report 14060419 ↗
• MalfunctionDec 6, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT A PATIENT'S PACEMAKER PRESENTED WITH PREMATURE BATTERY DEPLETION. NO CHANGES WERE REPORTED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12942955 ↗
• InjuryFeb 26, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2021 FOR A FOLLOW UP, WHERE THE PATIENT'S PACEMAKER WAS FOUND TO BE IN ELECTIVE REPLACEMENT INDICATOR MODE DUE TO PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2021. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11383550 ↗
• InjuryDec 13, 2020Failure to Capture; Pacemaker Found in Back-Up Mode; Failure to Capture; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED WITH THEIR IMPLANTABLE PACEMAKER EXHIBITING BACKUP VVI MODE. THE DEVICE ALSO EXHIBITED FAILURE TO CAPTURE, ALTHOUGH IT WAS UNKNOWN IF IT WAS RELATED TO THE BACKUP MODE. PATIENT WAS PUT ON TEMPORARY PACING SUPPORT. THE DEVICE WAS UNABLE TO BE RESET TO ITS ORIGINAL SETTINGS, SO IT WAS EXPLANTED AND REPLACED ON (B)(6) 2020 INSTEAD. PATIENT WAS DISCHARGED AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10997965 ↗
• InjuryNov 26, 2019Pacemaker Found in Back-Up Mode; No Pacing; Pacemaker Found in Back-Up Mode; No Pacing

  IT WAS REPORTED THAT UPON INTERROGATION, THE DEVICE WAS FOUND TO HAVE GONE INTO BACK UP VVI MODE. THE DEVICE FAILED TO PROVIDE IMPULSES INTERMITTENTLY. THE DEVICE WAS EXPLANTED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9380384 ↗
• InjuryMay 1, 2019Failure to Interrogate; Failure to Interrogate

  DURING A FOLLOW-UP IN CLINIC, THE DEVICE WAS UNABLE TO BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED AND THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8569304 ↗
• InjurySep 26, 2018Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode

  IT WAS REPORTED THAT THE DEVICE WAS NOTED TO BE AT ERI. UPON PRINTING DEVICE INFORMATION BACKUP VVI MESSAGE APPEARED. WHILE CLEARING THE BACKUP STATUS THE PROGRAMMER FROZE. THE PROGRAMMER WAS TURNED OFF. THE DEVICE WOULD NOT INTERROGATE AFTER. PATIENTS CONDITION STABLE. ON (B)(6) 2018, THE DEVICE WAS EXPLANTED AND DISCARDED. DEVICE WILL NOT BE RETURNED. PATIENTS CONDITION WAS STABLE PRE, INTRA AND POST PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7912699 ↗
• InjuryJun 22, 2018Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT WHEN PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP VISIT, DEVICE WAS UNABLE TO BE INTERROGATED WITH AN INDUCTIVE WAND ONLY. DEVICE HAS NOT BEEN CHECKED FOR THE PREVIOUS SIX MONTHS. A TELEMETRY TEST IN DIFFERENT ROOMS AND WITH DIFFERENT PROGRAMMERS WERE ATTEMPTED. PHYSICIAN ELECTED FOR DEVICE REPLACEMENT DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR. DEVICE WAS EXPLANTED AND A NEW DEVICE WAS IMPLANTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7631645 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P880086. One submission often covers many models, so check the product and lot details in each record.

• Z-1495-2022 · Jun 17, 2022 · Open, Classified
  Merlin PCS 3650 programmer Model 3330 software
• Z-1497-2022 · Jun 17, 2022 · Open, Classified
  Merlin.net model MN5000 Software
• Z-1496-2022 · Jun 17, 2022 · Open, Classified
  Merlin 2 PCS MER37000 programmer Model MER3400 software
• Z-0429-2012 · Sep 23, 2011 · Terminated
  Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0430-2012 · Sep 23, 2011 · Terminated
  Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.
• Z-0296-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510
• Z-0298-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)
• Z-0297-2007 · Oct 6, 2006 · Terminated
  St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650
• Z-0052-04 · Jul 31, 2003 · Terminated
  Pulse Generator